Bugs Drugs & Beyond: Janssen Focused Microbiome-based Health Solutions0

Johson & Johnson’s Janssen Pharmaceutical Companies – the human microbiota and health

As soon as he is born, man becomes the habitat of a very rich microbial flora. The skin, the mucous membranes and the gastrointestinal contents become stocked with such a flora, but a very small number of these microorganisms have up to the present been recognised or described…For long it was thought that in healthy individuals all these micro-organisms were inoffensive and sometimes even useful.”

– Elie Metchnikoff, 1901, The Prolongation of Life

Unprecedented healthcare opportunity

The microbiome refers to the complex community of microbial organisms that live in, on and around us. In the early twentieth century, Metchnikoff proposed a scientific rationale for the beneficial effects of bacteria, hypothesizing their importance in health for the first time. Today, we understand that bacteria and the microbiome play a crucial role in both sickness and health, with the potential to maintain health, as well as prevent, intercept and cure disease.

Driving Innovation

At the Janssen Pharmaceutical Companies of Johnson & Johnson, we’re interested in the human microbiome and the role ‘bugs’ play in impacting the health of consumers and patients, alike. We established the Janssen Human Microbiome Institute (JHMI) in 2015 to bring focus to microbiome expertise and innovations across Janssen and Johnson & Johnson. Headed by Dr. Dirk Gevers and headquartered in Cambridge, Massachusetts, the JHMI is a “one-stop shop” for microbiome innovators, offering experience and expertise to deliver microbiome-based health solutions to market.

The JHMI is working alongside researchers to deepen the understanding of host-microbe interactions, develop tools for standardized analytics, define regulatory pathways, and partner with the scientific community to advance translation of the science. Within the JHMI and across the J&J enterprise, our goal is to help innovators advance and bring about meaningful microbiome-based medicines, diagnostics, and solutions to individuals in order to improve and promote health and well-being.

IPSEN enters the field of probiotics with ‘Smebiocta®’0

Big Pharma & Microbiota together make for great innovation!

April 26th 2016, Probi and IPSEN officially announced the signature of a license and supply agreement for the commercialization of Probi’s probiotic strain Lactobacillus plantarum 299v (LP299V®). The agreement covers 18 countries, primarily within EU and emerging markets. One year after, IPSEN enters the field of probiotics by launching Smebiocta® – LP299V®, its first food supplement. Smebiocta® – LP299V® contains 10 billion of Lactobacillus plantarum 299v (LP299V®) per capsule, a unique Lactobacillus strain scientifically studied and rigorously selected. The product has strong medical endorsement that perfectly fits with Ipsen’s gastroenterology expertise and leverages Ipsen’s capabilities towards physicians and pharmacists in many countries. Read the full press release here.

This launch strengthens Ipsen’s Consumer Healthcare portfolio and fits with Ipsen’s strategy to bring this business unit back to growth, In early 2017, two other major announcements were made for acquisitions of new products and entities, particularly in France, Italy and Eastern Europe. This launch will help sustain Ipsen’s Consumer HealthCare growth and accelerate transition to the OTx (mix of physicians’ prescriptions, recommendations by pharmacists and patients’ demand originated through direct communication) model.
Learn more about Smebiocta® here (French market product website).

ProDigest SHIME® & PathoGut™0

“Two new assays to assess the effects of test compounds on Clostridium difficile infection”

A PRI member from nearly the beginning, ProDigest is a company based in Belgium which proposes services surrounding a proprietary technology platform known as SHIME (Simulator of the Human Intestinal Microbial Ecosystem). This dynamic simulation model of the gastrointestinal tract was developed at the University of Ghent Laboratory of Microbial Ecology and Technology (LabMET), and thus allowing this Belgian spin-off to come into being, founded by Dr. Sam Possemiers, Dr. Massimo Marzorati, and Dr. Willy Verstraete. Today ProDigest offers services based on the analysis of gastrointestinal transit, bioavailability, metabolism, immune modulation and efficacy of food compounds, functional ingredients and pharmaceuticals, to the Food, Pharma and Feed industries. ProDigest’s approach to their analysis is to mimic the intestinal environment, which allows them “to perform predictive studies on the behavior of actives in the gastrointestinal tract.”

According to recent research, C. difficile infection (CDI), which is caused by the Clostridium difficile bacterium, has become a leading cause of antibiotic-associated diarrhea, and can manifest in more serious ways, such as life-threatening pseudo-membranous colitis and toxic mega-colon. According to the research cited by ProDigest, “C. difficile typically causes infection when the healthy balance of the normal gut microbiota is disrupted, for instance due to the intake of antimicrobial agents.”

Treating CDI is typically done in a broad-spectrum approach (such as vancomycin and metronidazole), however these treatments tend to further disrupt the gut microbiota. “Disruption of the microbiota is one of the leading causes of recurrence of infection…”, according to the Belgian spin-off. The development of new treatments (such as antiobiotic therapy, immunotherapy, vaccines, pre- and probiotics and fæcal transplants) requires extensive research and new techniques to establish the efficacy of actives against C. difficile and their effect on the indigenous gut microbiota. ProDigest has developed an innovative screening assay using the SHIME technology platform.

Learn more about ProDigest’s innovative screening assays by clicking here.

To find out more about ProDigest’s approach and the services they provide, visit them their website, www.prodigest.eu.

Big Pharma and the Microbiota0

Many pharmaceutical leaders strangely quiet on the subject

Here at the PRI we’ve noticed an increase in the number of senior scientists from big pharmaceutical companies attending and presenting at the numerous conferences that have emerged around the Human Microbiome in recent years. Conferences in Amsterdam, Paris, London and Berlin have all featured senior strategic decision makers from companies such as Pfizer, Merck, J&J, Boeringher Ingelheim, Sanofi, Astra Zeneca and many more.

From the perspective of an association like the PRI whose objectives are the promotion of Microbiotic Medicinal Products such as LBPs (medicinal probiotics), Phages, FMTs, etc., this could only be seen as positive. The number of conferences is growing, there’s more interest from organisations with real financial clout, more and more start-ups/spin-offs, and plenty of wonderful buzz about the microbiome all around the globe. The science is certainly there and members of our association are all progressing in the right direction with several of them at stage 3 of clinical trials and with a strong chance of gaining drug market authorization in the very near future.

However, despite all of that, the commitment from ‘Big Pharma’ has been very low risk. I’ve listened intently to many presentations from these same senior scientists who demonstrate a strong understanding of the potential; and yet propose little in the way of action towards what may be the next revolution in health, personalized medicine (perhaps as fundamentally important as the x-ray and vaccines).

There are of course some exceptions: J&J has invested heavily through its pharmaceutical arm Janssen and their Human Microbiome Institute in Belgium which is enabling several start-ups to equip themselves with top notch R&D facilities, and there’s been plenty of movement from other pharmaceutical companies such as Ipsen and Ferring who are showing real ambition in this area as well. Merck have recently opened an exploratory science centre in Cambridge, Mass., which will be dedicated to microbiome research. However it is not yet known whether they will focus more on novel microbial drugs and therapies (Bugs as Drugs), or the more traditional Molecular route (drugs for Bugs). Boehringer Ingelheim has also developed along these lines in Connecticut.

The other big pharma companies remain quiet, watching the space. Most of the presentations that we have witnessed so far have seen these companies lay the emphasis on products and therapies along the traditional molecular route with no real desire to throw themselves into the complex world of microbes. Furthermore, the need for causation and mechanistic understanding which is possible with molecular drugs is not necessarily the right solution for microbial medicines where the ecosystem is completely different. Once again the option to sit and wait whilst the start-ups do the hard development seems to be the approach. Such is the way in the pharmaceutical industry!

In the meantime the complex regulatory challenges around these microbiotic medicinal products remain a challenge and will of course be obligatory for all partners at whatever stage they decide to commit themselves. Here at the PRI we are well-placed to assist companies who are looking to take their product or therapy to market in Europe as a medicine. We have the scientific desire from academics and start-ups, there are already several ambitious financial partners and funds involved but we will also need the support of all the major pharmaceutical companies involved in this arena to bring about the microbiome revolution.

PRI builds its network in the Microbiota & Human Health industry0

Business Developer working hard to grow the membership and make new contacts

The last 6 months have been very exciting for us here at the PRI in terms of networking and membership. With no fewer than 13 new members having joined since the New Year, our work in the Microbiota & Human Health Industry continues to help our members connect, gain insight, and tackle the industry’s challenges. The PRI Business Developer, Richard Ellis, has been hard at work in the office but also on the road meeting with industry players building on an already diverse network of partners and contacts. We here at the PRI feel 2017-2018 promises to be a defining year for Microbiotic Medicinal Products.

Two factors have contributed to our most recent successes in recruitment. Firstly, Richard Ellis has attended a number of microbiome/microbiota-themed events over the last few months, helping the PRI to gain important views on the state of the industry; the Microbiome R&D Business Collaboration Forum in Amsterdam, Vitafoods in Geneva, and the Microbiome Discovery & Development Congress in Berlin. And secondly, greater innovation and investment has lead to more and more need for regulatory insight and high-quality and targeted networking opportunities, both of which the PRI considers to be its specialties when it comes to Microbiotic Medicines.

Finally the PRI is proud to continue its partnership with I² Communications for next year’s Pharmabiotics 2018 Conference & Partnering Event, 14-15 March 2018, at the New Cap Conference Centre, Paris, France. Pharmabiotics 2018 is unique in that it combines cutting-edge presentations and regulatory affairs updates with high-quality and high-volume networking meetings.

Find out more about Pharmabiotics 2018 here.